Stopped: Change on clinical and marketing strategy for the devices
The purpose of this study is to compare OR3Oâ„¢ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA. Data collected in this study will be used to support National Medical Products Administration (NMPA) regulatory approval of OR3Oâ„¢ Dual Mobility System in China as well as to support and maintain product registration in global markets. Primary Objective: Assess safety and efficacy of the OR3Oâ„¢ Dual Mobility System in Primary THA at 1 year postoperative. Secondary Objective(s): Assess safety and efficacy of the OR3Oâ„¢ Dual Mobility System and compatible components in Primary THA up to 2 years after surgery. Other Objective(s): Assess the hip dislocation and hospital readmission up to 2 years after device implantation. 4 study sites in China.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants With Excellent or Good Harris Hip Score (HHS) at 12 Months
Timeframe: 12 months